FDA Adverse Event
Malfunction
Summary report: N
MEDLINE INDUSTRIES, INC.
MDR report key: 11723433
·
Received April 26, 2021
Report
- Report Number
- 11723433
- Event Type
- Malfunction
- Date Received
- April 26, 2021
- Date of Event
- March 26, 2021
- Report Date
- April 16, 2021
- Manufacturer
- MEDLINE INDUSTRIES, INC.
- Product Code
- OHG
- UDI-DI
- 10884389542040
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
HEALTH CARE PROVIDER REPORTED HEMOSTAT DID NOT CLAMP CORRECTLY, THERE WAS A GAP IN THE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623129 | MEDLINE INDUSTRIES, INC. | CIRCUMCISION TRAY | OHG | MEDLINE INDUSTRIES, INC. | DYNDF1072A | 10884389542040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA |